AstraZeneca and Merck announced that the FDA has accepted a supplemental New Drug Application (sNDA) for priority review for the approval of Lynparza tablets as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2019.
This is the first U.S. regulatory submission acceptance for a poly ADP-ribose polymerase (PARP) inhibitor in the first-line maintenance setting for advanced ovarian cancer, and, if approved, will be the fourth indication for Lynparza in the U.S.
This submission was based on positive results from the pivotal Phase 3 SOLO-1 trial. The trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for Lynparza compared to placebo, reducing the risk of disease progression or death by 70 percent in patients with newly-diagnosed, BRCAm advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy (HR=0.30 [95 percent CI 0.23-0.41]; p<0.001).
With a median 41 months of follow-up, the median PFS for patients treated with Lynparza (n=260) was not reached compared to 13.8 months for patients treated with placebo (n=131). Sixty percent of patients receiving Lynparza remained progression-free at 36 months, compared to 27 percent of patients in the placebo arm. These data were recently presented for the first time at the ESMO 2018 Congress (European Society for Medical Oncology) and published online in the New England Journal of Medicine.
Lynparza is a first-in-class PARP inhibitor approved in the U.S. since 2014. Lynparza has a broad clinical development program and AstraZeneca and Merck are working together to deliver Lynparza as quickly as possible to more patients across multiple cancer types.